← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

MNQStimulator, Hypoglossal Nerve, Implanted, Apnea

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
AN
ImplantLife-sustainingGMP-exemptThird-party review eligible
3
510(K)/PMA CLEARANCES
pma: 3
0
RECALL ENTRIES

Recent clearances

P130008Inspire Medical Systems · pma2026-07-10
P250013LivaNova USA, Inc. · pma2026-06-18
P240024Nyxoah S.A. · pma2026-06-08

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA enforcement & recalls

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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